Making initial contacts
Study start up activities
External consultant in clinical trials (Phase II-IV)
Regulatory submissions (Local Ethicall Committiess, Regulatory Agency)
Excellent communication/ negotiation skills for grants and contracts
Excellent understanding of the healthcare systems in B&H
Monitoring activities
(phases II-IV – pre-study, initiation, interim, and closeout visits.).
We also provide multiple trainings in required fields of services for clinical trials:
Legislative and Rules for Clinical Trials
ICF GCP
Declaration of Helsinki
Anticorruption and antibribery compliance
In our jurisdiction are:
Regulatory compliance
SAE reporting and requirements
Data management
Pharmacovigilance
Translations
We provide certified translations of the study related documentation and have capacities to provide services of drug safety monitoring along all product lifecycle, from clinical trial to post-marketing period.
Our partner is the company Parexel International, for which we do all the business in Bosnia and Herzegovina, as well as in the region.